Systems and methods for targeted electrical stimulation

Abstract

Provided herein are stimulation devices and methods of use thereof to generate a focused electric field for targeted electrical stimulation of muscle. The stimulation devices described herein may comprise a plurality of current sources electrically coupled to a plurality of electrodes that can deliver direct stimulation to muscle or an organ comprising a muscle. The current sources may be connected in series through the muscle or the organ comprising the muscle. Using the stimulation devices described herein, currents delivered to the electrodes can be independent of one another and adjusted to generate a focused electric field.

Description

SYSTEMS AND METHODS FOR TARGETED ELECTRICAL STIMULATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 588,500, filed October 6, 2023, the contents of which are incorporated by reference herein in their entirety.FIELD

[0002] This disclosure relates generally to targeted electrical stimulation of a muscle or an organ comprising a muscle, and more specifically to generating focused electric fields for targeted electrical stimulation of a muscle or an organ comprising muscle.BACKGROUND

[0003] Implantable medical devices can be used to electrically stimulate tissue in patients in order to treat a variety of medical conditions. For example, implantable devices may be used to stimulate muscles, organs, peripheral nerves, cardiac tissue, the brain, or other tissue for therapeutic treatment. Implantable devices can use voltage or current sources coupled to one or more electrodes to electrically stimulate tissue. The energy delivered to the electrodes via the current or voltage sources may be uniform and thus produces a uniform electric field for stimulating the tissue. Uniform electric fields are not ideal for stimulating organs in which characteristics of the tissue undesirably modulate the distribution of the electric field and therefore cause inaccurate stimulation of the tissue. For example, delivering a uniform energy source to a muscle or organ which varies in tissue impedance, such as the bladder, can lead to some areas of tissue intended for stimulation being under-stimulated or over-stimulated and other areas of tissue unintended for stimulation being stimulated.

[0004] To compensate for under-stimulation, administrators of the stimulation therapy may increase the overall amount of energy delivered to the electrodes via the current or voltage sources. However, uniformly increasing the energy delivered to the electrodes is also not ideal because it can result in further over-stimulation of other areas of tissue, which can cause damage to these areas of tissue. It can also increase the amount of tissue stimulated that is not intended for stimulation. Further, it can result in an unnecessarily high-power draw from the power source of the implantable device. For an implantable device that is already limited in energy storage capabilities due to its small size, the lifespan of the implantable device may be significantly reduced when the power draw is increased, which necessitatesmore frequent charging or replacement of the implantable device. Increasing the charging regimen or number of follow-up surgeries to replace the implantable device places considerable mental, physical, and economic burdens on patients.SUMMARY

[0005] Described herein are implantable devices for targeted electrical stimulation and methods of generating a focused electric field for electrical stimulation of muscle. The stimulation devices described herein may comprise a plurality of independent current sources configured to deliver independent currents to electrodes. Each of the currents delivered by the current sources can be independently adjustable to generate a focused electric field for targeted electrical stimulation. The amount of energy delivered to a given electrode via a current source coupled to the electrode can be modified, for example, based on the impedance of the tissue at the location of the implanted electrode. In this manner, a focused electric field produced by the various currents delivered to the plurality of electrodes can be generated for targeted electrical stimulation of the muscle. Using the implantable devices and targeted stimulation systems described herein, unintended distribution of energy to electrodes (or current sources coupled to the electrodes) can be avoided, thus preserving the state of the tissue at and around the implanted location of the electrodes and also preserving the lifespan of the implantable device. Moreover, a more customized, accurate, and effective electrical stimulation regimen of the muscle can be generated, thus improving health outcomes of the patient.

[0006] In some examples, a stimulation device is provided, comprising: a plurality of current sources; and a plurality of electrodes electrically coupled to the plurality of current sources, the plurality of electrodes configured to directly stimulate a muscle or an organ comprising a muscle, wherein each electrode of the plurality of electrodes is configured to be operated using an independent current source of the plurality of current sources. Each current source of the plurality of current sources can be electrically coupled in series through the muscle or the organ comprising the muscle to at least one other current source of the plurality of current sources. In some implementations, the independent current source of the plurality of current sources is configured to supply or absorb a current that is independent of currents supplied or absorbed by other current sources of the plurality of current sources. Currents supplied by the plurality of current sources may be adjustable by a control circuit electrically coupled to each current source of the plurality of current sources. In some examples of the stimulation device, at least one current source of the plurality of current sources is adjustablebetween supplying current or absorbing current by a control circuit electrically coupled to the at least one current source. A switch may be electrically coupled to the independent current source to control whether the independent current source supplies current to or absorbs current from the electrode.

[0007] The plurality of electrodes of the stimulation device may be configured to generate, based on independent currents from the plurality of current sources, a focusable electrical stimulation field for targeted stimulation of the muscle or the organ comprising a muscle. The electrical stimulation field may be, for example, a two-dimensional current field or a three-dimensional current field.

[0008] The stimulation device can include a control circuit electrically coupled to each current source of the plurality of current sources and configured to generate a current waveform to be delivered to the plurality of current sources. In some implementations of the device, the control circuit is configured to receive a command from an external device, the command configured to cause the control circuit to deliver the current waveform to one or more current sources of the plurality of current sources. The stimulation device may include, for example, one or more ultrasonic transducers, and the control circuit receives the command from ultrasonic waves emitted by the external device. The control circuit may be configured, for example, to communicate with the external device using ultrasonic backscatter. In another implementation of the device, the stimulation device includes a radio frequency (RF) antenna, and the control circuit receives the command from radio waves emitted by the external device. The control circuit may therefore be configured to communicate with the external device using radio wave backscatter.

[0009] In some implementation of the device, the stimulation device comprises a radiofrequency (RF) antenna, and the plurality of current sources are configured to receive energy from RF waves emitted by an external device. In other implementations of the device, the stimulation device comprises one or more ultrasonic transducers, and the plurality of current sources are configured to receive energy from ultrasonic waves emitted by the external device.

[0010] A first portion of the plurality of electrodes of the stimulation device may be disposed on a first paddle configured to be implanted at a first location in the muscle or the organ comprising a muscle and a second portion of the plurality of electrodes are disposed on a second paddle configured to be implanted at a second location in the muscle or the organ comprising a muscle. The first paddle and / or the second paddle can include, for example, a conductive shell that is configured as an electrode.

[0011] The stimulation device may include one or more stimulation leads that electrically couple each of the plurality of electrodes to an independent current source of the plurality of current sources.

[0012] In some implementations, the stimulation device further includes an energy storage electrically coupled to the plurality of current sources.

[0013] In some implementations, the plurality of electrodes comprises at least one anode and at least one cathode that together are configured to deliver bipolar stimulation to the muscle or the organ comprising a muscle.

[0014] In some implementations, at least a portion of the plurality of current sources are configured to act as current sinks that absorb current.

[0015] In some implementations, the plurality of current sources comprises one or more transistors.

[0016] In some implementations, the plurality of electrodes is configured to directly stimulate a bladder wall to trigger bladder voiding.

[0017] Also provided herein is stimulation system that includes the stimulation device and an external device configured to communicate with the stimulation device. Optionally, the system includes a magnet configured to power the stimulation device on and / or off.

[0018] In some examples, a method for generating a focused electric field to stimulate a muscle or an organ comprising a muscle is provided, comprising: delivering initial independent currents to a plurality of electrodes implanted on the muscle or the organ comprising a muscle; generating, by the plurality of electrodes, an initial electric field to stimulate the muscle or the organ comprising a muscle; delivering an updated independent current to one or more electrodes of the plurality of electrodes; and generating, by the plurality of electrodes, a focused electric field to directly stimulate the muscle or the organ comprising a muscle.

[0019] The method may include delivering an initial energy to the stimulation device; and stimulating the muscle or the organ comprising a muscle using an initial electric field generated by the plurality of electrodes using the initial energy delivered to the stimulation device. The energy may be delivered, for example, using an external device. In some implementations, the energy is delivered using ultrasonic waves emitted by the external device. In another example, the energy is delivered using radio waves emitted by the external device.

[0020] The method may further include transmitting one or more commands to the stimulation device indicating operating parameters of the stimulation device. The commandmay be, for example, encoded in ultrasonic waves emitted by the external device. In another example, the command is encoded in radio waves emitted by the external device.

[0021] Also provide herein is a method for treating a bladder incontinence in a subject in need of treatment for the bladder incontinence, comprising administering electrical stimulation using the stimulation device described herein.

[0022] Further described is a method for generating a focused electric field to stimulate a muscle or an organ comprising a muscle, comprising delivering initial independent currents to a plurality of electrodes implanted on the muscle or the organ comprising a muscle; generating, by the plurality of electrodes, an initial electric field to stimulate the muscle or the organ comprising a muscle; delivering an updated independent current to one or more electrodes of the plurality of electrodes; and generating, by the plurality of electrodes, a focused electric field to directly stimulate the muscle or the organ comprising a muscle. The initial electric field and / or the focused electric field are a two-dimensional current field or a three-dimensional current field. In some implementations, the initial independent currents delivered to the plurality of electrodes are supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes. Each electrode of the plurality of electrodes may be operated using an independent current source of the plurality of current sources and each of the plurality of current sources are configured to absorb or supply a current that is independent of currents supplied or absorbed by other current sources of the plurality of current sources. Currents supplied by the plurality of current sources may be adjustable by a control circuit electrically coupled to each current source of the plurality of current sources. At least one current source of the plurality of current sources may be, in some implementations, adjustable between supplying current or absorbing current by a control circuit electrically coupled to the at least one current source. A switch electrically coupled to the independent current source of the plurality of current sources may be configured to control whether the independent current source supplies current to or absorbs current from the electrode.

[0023] Delivering an updated independent current to one or more electrodes of the plurality of electrodes, according to some implementations of the method, can include updating one or more operating parameters of one or more current sources of the plurality of electrodes electrically coupled to the one or more electrodes to cause the one or more current sources to deliver the updated independent current. In some examples, delivering an updated independent current to one or more electrodes of the plurality of electrodes comprises updating a current waveform delivered to the one or more current sources.

[0024] The updated independent current delivered to a given electrode of the one or more electrodes may be, in some embodiments, less than the initial independent current delivered to the given electrode of the one or more electrodes. In another example, the updated independent current delivered to a given electrode of the one or more electrodes is greater than the initial independent current delivered to the given electrode of the one or more electrodes. In other examples of the method, delivering an updated independent current to a given electrode of the one or more electrodes includes delivering no current to the given electrode of the one or more electrodes.

[0025] The plurality of electrodes of the device used in the method can include at least one anode and at least one cathode that together deliver bipolar stimulation to the muscle or the organ comprising a muscle when the initial electric field and / or the focused electric field are generated.

[0026] In some examples of the method, the method may include receiving energy from an external device. For example, the energy may be received from ultrasonic waves emitted by the external device. In another example, the energy may be received from radio waves emitted by the external device.

[0027] In some implementations of the method, the method can include receiving, from an external device, a command indicating that the initial independent currents should be delivered to the plurality of electrodes; and delivering the initial independent currents to the one or more electrodes of the plurality of electrodes. The command may be, for example, encoded in ultrasonic waves emitted by the external device. In another example, the command is encoded in radio waves emitted by the external device.

[0028] In some implementations of the method, the method can include receiving, from an external device, a command indicating that the initial independent current delivered to one or more electrodes of the plurality of electrodes should be updated; and delivering the updated independent current to the one or more electrodes of the plurality of electrodes. The command may be, for example, encoded in ultrasonic waves emitted by the external device. In another example, the command is encoded in radio waves emitted by the external device.

[0029] In some implementations of the method, the method comprises communicating with an external device using ultrasonic backscatter. In another example, the method includes communicating with an external device using radio wave backscatter.

[0030] Further described herein is a method for treating a bladder incontinence in a subject in need of treatment for the bladder incontinence, comprising administering electrical stimulation in accordance with the method described above.BRIEF DESCRIPTION OF THE FIGURES

[0031] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of illustrative embodiments and the accompanying drawings.

[0032] FIG. 1A illustrates a schematic of a first exemplary targeted electrical stimulation device on an organ comprising a muscle, in accordance with some embodiments.

[0033] FIG. IB illustrates a schematic of another exemplary targeted electrical stimulation device, in accordance with some embodiments.

[0034] FIG. 1C illustrates a schematic of another exemplary targeted electrical stimulation device, in accordance with some embodiments.

[0035] FIG. ID illustrates a schematic of another exemplary targeted electrical stimulation device, in accordance with some embodiments.

[0036] FIG. 2 illustrates a block diagram of a first exemplary electrical stimulation system, in accordance with some embodiments.

[0037] FIG. 3 illustrates a block diagram of another exemplary electrical stimulation system, in accordance with some embodiments.

[0038] FIG. 4 illustrates a schematic of a non-targeted electrical stimulation device on an organ comprising a muscle, in accordance with some embodiments.

[0039] FIG. 5 illustrates a method for generating a focused electric field for targeted electrical stimulation, in accordance with some embodiments.DETAILED DESCRIPTION

[0040] Described herein are implantable systems and devices for targeted electrical stimulation and methods of generating a focused electric field for electrically stimulating tissue. The targeted electrical stimulation systems may comprise a plurality of current sources electrically coupled to a plurality of electrodes, the current sources connected in series through a muscle or organ comprising a muscle. Each of the current sources may be configured to deliver an independent current to a given electrode, and in combination, the energy at the plurality of electrodes may generate a focused electric field. The currents delivered to electrodes can be adjusted to accommodate for varying tissue impedance throughout the muscle as well as to target the intended stimulation location, thereby reducingunintended electrical stimulation of other regions of the muscle and also preserving the lifespan of the stimulation device by reducing the power expended by the device.

[0041] The following disclosure describes targeted electrical stimulation devices and systems in accordance with several embodiments. The disclosure also provides methods for generating a focused electric field for targeted stimulation, methods for electrically stimulating tissue with a focused electric field generated using the electrical stimulation systems described herein, and methods for treatment using the electrical stimulation systems described herein.Stimulation Devices and Systems

[0042] An exemplary stimulation device may comprise one or more current sources coupled to one or more electrodes. FIGS. 1A-1D illustrate a schematic of a targeted electrical stimulation device 100, in accordance with some embodiments. As shown in FIG. 1A, the device 100 may comprise a first plurality of current sources 102a, 102b, 102c, and 102d (collectively referred to hereinafter for simplicity as current sources 102). The device 100 may comprise a second plurality of current sources 104a, 104b, 104c, and 104d (collectively referred to hereinafter for simplicity as current sources 104). The device 100 may comprise any number of current sources 102, 104. For example, the device 100 may comprise 2, 3, 4, 5, 6, 7, 8, 9, 10 or more current sources 102, 104.

[0043] Each of the first current sources 102 may be electrically coupled in series through a muscle 108 or organ comprising the muscle to at least one of the second current sources 104. For example, as shown in FIG. 1A, current source 102a may be coupled in series to current source 104a, 104b, 104c, and / or 102d. Current source 102b may be coupled through the muscle or organ comprising a muscle in series to current source 104a, 104b, 104c, and / or 104d, and so on. In some embodiments, a first current source 102 (e.g., current source 102c) may be coupled in series through the muscle or organ comprising a muscle to a plurality of current sources 104 (e.g., current sources 104c, 104d). The opposite scenario may also occur in which a plurality of first current sources 102 (e.g., current sources 102a, 102b, 102c, and / or 102d) may be electrically coupled in series through the muscle or organ comprising a muscle to a second current source 104 (e.g., current source 104a). Other configurations of the current sources 102, 104 are understood to be encompassed in the scope of the disclosure.

[0044] In some embodiments, one of the first plurality of current sources 102 or the second plurality of current sources 104 may be current sinks. For example, the first plurality of current sources 102 may be current sources, whereas the second plurality of currentsources 104 may be current sinks. In this manner, current sources 102 may supply current, and current sources 104 may receive (or absorb) the current transmitted through the tissue by the current sources 102. The opposite scenario may also occur in which current sources 102 can be current sinks and current sources 104 can be current sources, the current sources 102 configured to absorb current supplied by current sources 104. In some embodiments, a first portion of current sources 102 may be current sources and a second portion of current sources 102 may be current sinks. In a similar manner, a first portion of current sources 104 may be current sources and a second portion of current sources 104 may be current sinks. In some embodiments, the current sources may be configured to operate as a source or a sink based on parameters programmed to the stimulation device.

[0045] The arrangement of the current sources 102, 104 on the muscle or organ 108 in FIG. 1 A is not intended to be limited to opposing sides of a target stimulation region. Moreover, the current may be supplied by the current sources and to the electrodes in any direction and is not limited to the illustrated bottom-to-top (or top-to-bottom) configuration. FIGS. 1B-1D illustrate additional example current source and electrode configurations. FIG. IB illustrates a stimulation system 100 in which the direction of current delivered to electrodes 106a and in turn received by electrodes 106b can alternate. FIGS. 1C-1D illustrate stimulation systems 100 in which each of a current source 102 and a current source 104 are electrically coupled to a single electrode 106, wherein one of current source 102 or 104 may be configured as a current sink (as will be described in greater detail below). Whether current is delivered to the electrode 106 from a current source 102 or received from the electrode 106 from a current source 104 can be controlled by a control circuit coupled to the current sources 102, 104 (as shown in FIG. 2). As shown in FIG. ID, the control circuit may control one or more switches 105 electrically coupled to the current sources 102, 104 to control whether current is delivered to or received from the electrode 106.

[0046] In any scenario, each of the current sources (e.g., current sources 102a, 102b, 104a, 104b, etc.) may be configured to supply and / or receive a current that is independent of currents supplied / received by other current sources of the plurality of current sources 102, 104. For example, current source 102a may deliver a first current to electrode 106a, whereas current source 102b may deliver a second current to electrode 106b. The first current and the second current may be different. The first current may be greater than, less than, or equal to the second current. Current source 104a may be configured to receive a third current based on the first current and / or second current delivered by current sources 102a, 102b, respectively. The third current received at current source 104 may be a combination of at least a portion ofthe first current and at least a portion of the second current. Current source 104b may be configured to receive a fourth current based on the first current and / or second current delivered by current sources 102a, 102b, respectively. The fourth current received at current source 104 may be a combination of at least a portion of the first current and at least a portion of the second current. The third current received at current source 104a may be greater than, about equal to, or less than the current received at current source 104b. Each of the first, second, third, and fourth currents may be supplied and received independent of one another. One or more of the currents may be the substantially the same, or one or more of the currents may be different. As will be described in greater detail below, each of the currents supplied by current sources 102 and / or current sources 104 may be independently adjustable.

[0047] The current sources 102, 104 may be an electronic circuit or component thereof configured to deliver electric current. A current sink may be an electronic circuit or component thereof configured to absorb electric current. As described herein, one or more of the current sources may additionally or alternatively function as a current sink. In some embodiments, the plurality of current sources 102, 104 may comprise one or more operational amplifiers (op-amps). In some embodiments, the plurality of current sources 102, 104 may comprise one or more transistors. Exemplary transistors that may be utilized to implement current sources 102, 104 may include metal-oxide-semiconductor field-effect transistors (MOSFETs) such as NMOS transistors, PMOS transistors, and CMOS transistors. In some embodiments, one or more of the current sources 102, 104 may be implemented using current sources (and / or sinks) that can dynamically adjust their resistance to account for changes in current. Such current sources may be circuits that comprise transistors such as MOSFETs.

[0048] As mentioned above and demonstrated in device 100 in FIGS. 1A-1D, the stimulation device 100 may comprise a plurality of electrodes 106, such as electrode 106a, 106b, 106c, 106d (collectively referred to as electrodes 106 hereinafter for simplicity). As shown in FIG. 1A, each electrode 106 may be coupled to one or more current sources 102 and / or one or more current sources 104, such as via one or more leads 116. The plurality of electrodes 106 may be configured to directly stimulate a muscle 108 or an organ comprising a muscle. For example, the plurality of electrodes 106 may be implemented in an implantable device for stimulation of the muscle (e.g., tissue of the muscle) or an organ comprising muscle that the device is implanted in.

[0049] In some embodiments, the electrodes 106 may comprise one or more epimysial electrodes configured to be implanted directly onto a muscle or an organ comprising amuscle. The epimysial electrodes can be surgically attached to the tissue surrounding the muscle (e.g., the epimysium). For example, the electrodes 106 may be disposed on one or more paddles configured to be implanted on the muscle or organ comprising the muscle, as described herein with respect to device 300 and FIG. 3. In some embodiments, the electrodes 106 may comprise one or more button electrodes. In some embodiments, the electrodes 106 may be platinum-iridium electrodes that can be fixed to (and / or surrounded by) an insulated substrate (e.g., silicone) to minimize spread of current to other excitable areas of the muscle (or organ comprising the muscle). For example, one or more electrodes 106 may be molded into a medical-grade silicone substrate paddle.

[0050] In some embodiments, one or more of the electrodes 106 may be electrically coupled to each other. For example, as described herein, one or more electrodes 106 may be electrically coupled in series through the muscle or organ comprising the muscle. Stated otherwise, the plurality of electrodes may comprise at least one anode and at least one cathode that together are configured to deliver bipolar stimulation to the muscle 108 or organ comprising the muscle. The anodes and cathodes are demonstrated in FIGS. 1 A- IB by the minus and plus signs, respectively. With reference to FIG. 1A, electrode 106a may be electrically coupled through the muscle or organ comprising the muscle to electrodes 106c and / or 106d. Similarly, electrode 106b may be electrically coupled to electrodes 106c and / or 106d. As shown, the current source (e.g., current source 102a) may be electrically coupled to a cathode electrode 106a, and the current sink (e.g., current source 104a) may be electrically coupled to an anode electrode 106c. In some embodiments, a given anode and cathode may be disposed within about 5-20 mm of one another, such as about 10 mm apart from one another.

[0051] Each electrode of the plurality of electrodes 106 may be configured to be operated using an independent current source of the current sources 102, 104. For example, electrode 106a may be electrically coupled to and operated by current source 102a. In this instance, current source 102a may supply a current to the electrode 106a, which can be delivered to the muscle or organ comprising a muscle before being received at least at electrode 106c, which can transmit the received current to the current source 104a (operating as a current sink). The opposite scenario may occur in which the current source 104a can be configured to supply current to the electrode 106c, at least a portion of which may then be received by current source 102a (via electrode 106a). The current supplied to electrode 106a may be used to deliver electrical stimulation to the muscle 108 or organ comprising the muscle at / around the electrode 106a. The same or a similar configuration of electrodes 106b and 106d may apply.For example, electrode 106b may be electrically coupled to current source 102b, and electrode 106d may be electrically coupled to current source 104b. Either current sources 102 or 104 (or combinations thereol) may supply and / or receive the current that is passed through the electrodes 106.

[0052] In some embodiments, a given electrode 106 (e.g., electrode 106a) may be electrically coupled to a plurality of current sources 102, 104. For example, FIGS. 1C-1D illustrate stimulation systems 100 comprising an electrode 106 that may be electrically coupled to a current source 102 configured to supply current, and a current source 104 configured to absorb current (e.g., a current sink). The electrode 106 may be operably programmed as an anode or a cathode. The current sources 102, 104 may be interchangeably configured as current sources and / or sinks. For example, the current sources 102, 104 may be electrically coupled to a control circuit configured to control whether the current sources 102, 104 are configured to absorb or supply current. Further, the control circuit may control whether, at a given instance, the current source (e.g., current source 102) can deliver current to the electrode 106 or whether the current sink (e.g., current source 104) can absorb current from the electrode 106. In a similar manner, FIG. ID illustrates current sources 102, 104 electrically coupled to a switch 105 configured to control whether current is delivered to the electrode 106 (e.g., from a current source 102) or absorbed from the electrode 106 (e.g., at a current source 104). The switch 105 may be controlled by a control circuit.

[0053] In some embodiments, each of the current sources 102, 104 may be independently electrically coupled to a control circuit for controlling the current delivered to each of the electrodes 106. The manner by which the current sources 102, 104 can control the current at electrodes 106 (e.g., via the control circuit of the device) is described in greater detail below with reference to FIG. 2.

[0054] In some embodiments, one or more cathode electrodes may be electrically coupled (e.g., via one or more leads) to one or more other cathode electrodes of the stimulation system 100. For example, electrode 106a may be electrically coupled to electrode 106b. Similarly, in some embodiments, one or more anode electrodes may be electrically coupled (e.g., via one or more leads) to one or more other anode electrodes. For example, electrode 106c may be electrically coupled to electrode 106d. In some embodiments, anode electrodes may not be electrically coupled to other anode electrodes, and / or cathode electrodes may not be electrically coupled to other cathode electrodes. In any instance, a given electrode (e.g., electrode 106a) may be disposed proximal to another electrode (e.g., electrode 106b) to generate at least a portion of a focusable electric field.

[0055] The arrangement of the electrodes 106 is not intended to be limited to the horizontal, linear fashion shown in FIGS. 1A-1D. For example, the electrodes 106 may be arranged in a linear fashion oriented in a different direction (e.g., vertical, diagonal or otherwise), along a curve (in any orientation), in a shape (e.g., circular, ovular, triangular, rectangular, or another polygon oriented in any manner), in a zig-zag, or in no particular pattern (e.g., randomly). The arrangement of the electrodes 106 may be designed to best achieve electrical stimulation with the electrodes 106 on the intended muscle 108 or organ comprising the muscle. Moreover, as mentioned above, the illustrated arrangement of the current sources 102, 104 relative to the electrodes is merely for illustration purposes. One of ordinary skill in the art will understand that the current sources 102, 104 can be implemented in circuitry of the stimulation system 100 that is not limited to the arrangement depicted in FIGS. 1A-1D. Rather, the electrical configuration between current sources 102, 104 (via one or more electrodes 106) may be important. As mentioned above, the plurality of current sources 102 may be electrically coupled in series through the muscle 108 or organ comprising the muscle to at least one other current source of the plurality of current sources 104.

[0056] In some embodiments, the plurality of electrodes 106 may be configured to generate, using the independent currents delivered by the current sources 102 (and / or current sources 104), a focusable electrical stimulation field 110 for targeted electrical stimulation of the muscle 108 or the organ comprising a muscle. The electrical stimulation field 110 may be a two-dimensional (2D) or three-dimensional (3D) current field. As explained herein, the muscle 108 or organ comprising muscle may have a variable tissue impedance (or resistance) dependent on the region of the muscle. For example, the tissue impedance 108a in a first region of the muscle 108 may be different from tissue impedance 108b in a second region of the muscle 108 different from the first region. These variations in tissue impedance throughout the muscle may affect the electrical stimulation field 110 generated based on the current delivered to the electrodes 106. To account for these variations, the device 100 may be configured to deliver independent currents to the electrodes 106 by the current sources 102 (and / or current sources 104). In this manner, a focusable electrical stimulation field 110 can be generated.

[0057] In some embodiments, the muscle 108 may be a muscle of the bladder wall (e.g., sphincter muscles). It may be challenging to directly stimulate these muscles of the bladder wall. Thus, using the targeted electrical stimulation devices described herein, the plurality of electrodes 106 may be configured to directly stimulate the muscles of the bladder wall, for example, to trigger bladder voiding.

[0058] In some embodiments, the device 100 may be configured to generate an electric field (e.g., a current field) with a predetermined field strength. The field strength may be adjustable to effectively stimulate the bladder wall.

[0059] The above-described focusable electrical stimulation field 110 is in contrast to an electrical stimulation field generated by a uniform voltage (or current) source. For example, FIG. 4 demonstrate an electrical stimulation device 400 in which the voltage sources 452, 454 are configured to deliver a uniform voltage to the electrodes 456a, 456b (collectively referred to hereinafter as electrodes 456). The voltage sources 452, 454 may alternatively be current sources that deliver a uniform current to the electrodes 456. Based on this voltage (or current), the electrodes 456 may generate a uniform electrical stimulation field 462 irrespective of variable tissue impedances in the muscle 458 or organ comprising the muscle. The various tissue impedances throughout a given muscle or organ (e.g., the bladder) may cause certain regions of the muscle / organ to receive stimulation more readily than other regions, which can negatively affect the efficacy of the stimulation regimen.

[0060] Moreover, the electrical stimulation field 462 may not accurately capture the target stimulation region of the muscle 458 or organ comprising the muscle. For example, the target stimulation region 460 may be only a fraction of the size of the large electrical stimulation field 462, as shown in FIG. 4. In this instance, areas that may not need treatment may be affected by the electrical stimulation field 462, which is a poor use of the limited energy resources of the implantable device. In another (not pictured) example, the arrangement of the electrodes 456 on the stimulation device may not accurately capture the intended stimulation region(s) of the muscle 458 or the organ comprising the muscle. Generating an electrical stimulation field 462 by uniformly applying a voltage (or current) at the electrodes 456 may not adequately stimulate (e.g., may under-stimulate) the target stimulation region 460. In this instance, the administrator of the stimulation regimen may increase the energy delivered to the electrodes 456 to attempt to stimulate the target stimulation region 460, which can cause over-stimulation of unintended areas of the muscle 458 or organ comprising the muscle. This over-stimulation of tissue can negatively affect the tissue and wastefully expend the power source of the stimulation device.

[0061] FIG. 2 illustrates a block diagram of a first exemplary electrical stimulation system, in accordance with some embodiments. The electrical stimulation system 230 may include a stimulation device 200 that comprises any one or more features of stimulation device 100 described herein with respect to FIGS. 1A-1D. For example, current sources 202, 204 may comprise any one or more features of current sources 102, 104 (respectively) ofdevice 100, and electrodes 206 (e.g., electrodes 206a, 206b, collectively referred to hereinafter as electrodes 206) may comprise any one or more features of electrodes 106 of device 100. The current sources 202 may in some embodiments comprise one or more transistors. The plurality of electrodes 206 may comprise one or more anodes and one or more cathodes configured to deliver bipolar stimulation.

[0062] The stimulation system 230 (e.g., stimulation device 200) may comprise a control circuit 212 for controlling the current delivered to the current sources 202. For example, the control circuit 212 may be configured to generate one or more current waveforms (otherwise referred to herein more simply as currents) that can be delivered to the plurality of current sources 202. The control circuit 212 may more generally control the flow and storage of energy and information within the stimulation device 200. Control circuit 212 may be electrically coupled to each current source of the plurality of current sources 202 via a lead 216, as illustrated by the solid line connecting the blocks for current sources 202 and control circuit 212.

[0063] In some embodiments, the control circuit 212 may comprise an applicationspecific integrated circuit (ASIC) and / or a low-power microcontroller configured to control the ASIC and other electronic components of the stimulation device 200.

[0064] In some embodiments, the stimulation device 200 may comprise one or more leads 216 (e.g., stimulation leads) that can electrically couple each electrode of the plurality of electrodes 206 to one or more independent current sources of the plurality of current sources 202, 204. The leads 216 may be similar in size, material, construction methods, contact geometry, etc. to leads commonly used in the field. For example, leads 216 may be 1- 2 mm in diameter, comprise ethylene tetrafluoroethylene copolymer (ETFE) conductive wire insulation material, and / or 55D urethane lead body material.

[0065] An exemplary stimulation system may comprise the stimulation device 200 and an external device 220 configured to communicate with the stimulation device 200. For example, the control circuit 212 of the stimulation device 200 may be communicatively coupled to an external device 220. The control circuit 212 may be configured to receive a command from the external device 220 to cause the control circuit 212 to deliver a current waveform to one or more current sources of the plurality of current sources 202. The stimulation device 200 may be configured to receive energy transmitted by the external device 220. Stimulation device 200 may be configured to receive energy from external device 220 whenever external device 220 is placed in a position proximal to the implanted location of stimulation device 200. In some embodiments, external device 220 may be a separatedevice that is (at least partially) implanted in the patient. In such cases, external device 220 may be programmed to deliver energy to stimulation device 200 periodically. In some embodiments, external device 220 may be configured to be remotely controlled by a device such as a smart phone or a computer (e.g., the patient’s smart phone) and may transmit energy to stimulation device 200 whenever an appropriate command is received from the remote device.

[0066] In some embodiments, the external device 220 and the control circuit 212 may be communicatively coupled by a transducer 214 configured to wirelessly receive and transmit energy and / or commands between the stimulation device 200 (e.g., the control circuit 212 of the stimulation device 200) and the external device 220. These commands received at the transducer 214 may indicate operating parameters of the stimulation device 200. In some embodiments, transducer 214 may be configured to convert energy received from the external device 220 into electric current. In some embodiments, stimulation device 200 may comprise a communication circuit electrically coupled to and configured to operate the transducer 214.

[0067] In some embodiments, the transducer 214 may comprise one or more ultrasonic transducers. In this manner, the control circuit 212 may receive commands from ultrasonic waves emitted by the external device 220. In some embodiments, the current sources 202 may be configured to receive energy from ultrasonic waves emitted by the external device 220. Example ultrasonic transducers include but are not limited to a bulk piezoelectric transducer, a piezoelectric micro-machined transducer, or a capacitive micro-machined transducer, each of which can be configured to convert energy carried by ultrasonic waves emitted by the external device 220 into electric current signals.

[0068] In some embodiments, the transducer may comprise one or more radiofrequency (RF) antennas or one or more RF coils. In this manner, the control circuit 212 may receive commands from radio waves emitted by the external device 220. In some embodiments, the current sources 202 may be configured to receive energy from RF waves emitted by the external device 220. The RF antennas and / or coils may be configured to convert energy carried by RF waves into electric current signals.

[0069] In some embodiments, transfer of information from stimulation device 200 to external device 220 may rely on a backscatter communication protocol. For example, the control circuit 212 may communicate with the external device 220 using ultrasonic backscatter or radio wave backscatter. External device 220, as discussed, may be configured to transmit wireless signals (e.g., ultrasonic signals or RF signals) to stimulation device 200. When the patient wishes to retrieve information from stimulation device 200, control circuit212 may cause a modulation circuit of the stimulation device 200 to encode the information in electric current flowing through stimulation device 200. The encoded current may be transmitted from the modulation circuit to the transducer 214, which may convert the encoded current into an encoded wireless signal (e.g., an ultrasonic signal or an RF signal) of the same type emitted by external device 220. This encoded wireless signal (the “backscatter” signal) may be emitted by transducer 214 and subsequently received by external device 220. The external device 220 may then decipher the backscatter signal to retrieve the encoded information.

[0070] In addition to or instead of backscatter communication, transfer of information from stimulation device 200 to external device 220 may rely on an active communication protocol (e.g., active radio wave or ultrasonic wave transmission). Active radio wave or ultrasonic transmission may be modulated using Amplitude modulation (AM), Frequency modulation (FM), Phase modulation (PM), Pulse-code modulation (PCM), Polarization modulation, Quadrature amplitude modulation (QAM), or any other appropriate modulation scheme. In such embodiments, control circuit 212 may cause transducer 214 to generate and transmit a signal that encodes information. External device 220 may receive and decode said signal in order to retrieve the encoded information. In some embodiments, the stimulation device 200 may comprise an energy storage 218. The energy storage 218 (e.g., a capacitor) may be independently electrically coupled to the current sources 202 and electrically coupled to the transducer 214. To minimize size, stimulation device 200 may include only a small energy storage 218 (e.g., a small capacitor). This energy storage 218 may need to be charged on a regular basis in order for stimulation device 200 to provide therapy to the patient. For example, as described herein, energy for charging the energy storage 218 may be delivered to stimulation device 200 by an external device 220. In some embodiments, the stimulation device 200 may comprise an AC / DC rectifier configured to transform current from the transducer 214 from an alternating current (AC) signal to a direct current (DC) signal, which can be used to charge energy storage 218.

[0071] In some embodiments, the stimulation device 200 may comprise a power management unit configured to store and distribute energy to components of the device (understood to encompass the energy storage 218), a modulation circuit configured to encode information in an electric current, a transmitter configured to wirelessly receive, convert, and transfer energy from the external device 220, and / or a memory configured to store data received from one or more sensors (e.g., electrodes 206).

[0072] In some embodiments, an exemplary stimulation system 230 may comprise the stimulation device 200 and external device 220 described herein, as well as an external magnet. The magnet may be configured to power the stimulation device 200 on and off, for example, by moving the magnet in proximity to the stimulation device 200.

[0073] FIG. 3 illustrates a block diagram of a second exemplary electrical stimulation device, in accordance with some embodiments. The stimulation device 300 may comprise any one or more features of stimulation device 100 and / or stimulation device 200 described herein with respect to FIGS. 1 and 2, respectively. For example, electrodes 306a, 306b may comprise any one or more features of electrodes 106, 206 described herein with respect to FIGS. 1A-1D and 2. Current sources 302a, 302b may comprise any one or more features of current sources 102, 202 described herein with respect to FIGS. 1 A-1D and 2. Current sources 304a, 304b may comprise any one or more features of current sources 104, 204 described herein with respect to FIGS. 1A-1D and 2. Control circuit 312 may comprise any one or more features of control circuit 212 described herein with respect to FIG. 2.

[0074] FIG. 3 can demonstrate a device 300 in which components of the device may be distributed in different areas relative to the patient. For example, the device 300 may comprise one or more paddles 300a, 300b that can be implanted at a region of interest on a muscle 308, organ comprising a muscle, etc. Additionally, as shown in FIG. 3, the device 300 may comprise a control unit 300c that comprises the control circuit 312 and can be electrically coupled to the paddles 300a, 300b. This control unit 300c may be implanted remotely from or proximate to the one or more paddles 300a, 300b. In some embodiments, the control unit 300c may not be implanted into the patient and may instead be an external device. The control unit 300c may comprise any one or more components described herein with respect to stimulation device 200 illustrated in FIG. 2. For example, the control unit 300c may comprise one or more transducers, an energy storage, etc., not illustrated for simplicity.

[0075] In some embodiments, one or more electrodes 306a may be disposed on a first paddle 300a and one or more electrodes 306b may be disposed on a second paddle 300b. The electrodes may be anodes, cathodes, or may be configured to be interchangeable between an anode and a cathode. As shown in FIG. 3, the first paddle 300a may be implanted at a first location in the muscle 308 or organ comprising the muscle, and the second paddle 300b may be implanted at a second location in the muscle 308 (or organ comprising the muscle). In some embodiments, the first paddle 300a and / or the second paddle 300b may comprise a conductive shell that can act as an electrode. As described herein, the paddles 300a, 300bmay comprise an insulated substrate such as silicone that can surround the electrodes 306a, 306b to prevent the spread of stimulation current to unintended regions of the muscle or organ comprising muscle.

[0076] Each electrode 306a, 306b may be coupled to one or more current sources. For example, one or more leads (e.g., stimulation leads) may electrically couple electrode 306a to one or more current sources 302a, 304a. Likewise, one or more leads may electrically couple electrode 306b to one or more current sources 302b, 304b. In some embodiments, paddle 300a may comprise one or more electrodes 306a, each of which may be coupled to an independent current source 302a, and paddle 300b may comprise one or more electrodes 306b, each of which may be coupled to a current source 304b (e.g., a current sink). In other words, paddle 300a may comprise electrode(s) independently electrically coupled to current source(s), and the paddle 300b may comprise electrode(s) independently electrically coupled to current sink(s) (or vice versa).

[0077] In some embodiments, one or more of the components 300a, 300b, 300c may be reasonably combined, or one of the paddles 300a or 300b may be omitted. For example, an exemplary device may comprise two components - a paddle 300a comprising one or more electrodes 306a coupled to independent current sources 302a, 304a and a control unit 300c comprising at least the control circuit 312 and coupled (e.g., via one or more leads) to the current sources 302a, 304a disposed on the paddle 300a. In another example, a single paddle (e.g., paddle 300a) may comprise features of paddle 300a and 300b described herein. In another example, an implantable paddle (e.g., paddle 300b) may comprise features of paddle 300b and control unit 300c. In this scenario, the system may furthermore comprise an additional paddle 300a coupled to the combined paddle and control unit for stimulating the muscle 308 or organ comprising the muscle in a different region at which the paddle 300a is implanted.Methods for Generating a Focused Electric Field

[0078] FIG. 5 illustrates a method 500 for generating a focused electric field to stimulate a muscle or an organ comprising a muscle, in accordance with some embodiments. For example, the method 500 may be used to stimulate a bladder wall (e.g., sphincter muscles of the bladder). The method may comprise, prior to beginning stimulation, receiving energy (e.g., initial energy) at the stimulation device (e.g., stimulation device 100, 200, or 300) from an external device (e.g., external device 220), for example, to provide power to the device. For example, the external device may be used to charge the stimulation device. In someembodiments, the energy may be received from ultrasonic waves emitted by the external device. Alternatively, the energy may be received from radio waves emitted by the external device.

[0079] At step 502, the method 500 may comprise delivering initial independent currents to a plurality of electrodes implanted on the muscle or the organ comprising a muscle. For example, a current source of a first plurality of current sources may supply an independent current to an electrode, and a current source of the second plurality of current sources may receive the independent current supplied to the electrode. Each of the current sources may be configured to generate or receive independent currents that may be of varying magnitudes and / or waveforms. The current source of the first plurality of current sources and the current source of the second plurality of current sources may be coupled in series through the muscle or organ comprising the muscle (with at least one electrode electrically coupled to current sources). In this manner, each electrode of the plurality of electrodes may be operated using an independent current source of the plurality of current sources. In some embodiments, a given electrode of the plurality of electrodes may be coupled to a plurality of current sources, for example a current source configured to deliver current to the electrode, and a current sink configured to absorb current from the electrode.

[0080] In some embodiments, the initial independent currents may be delivered to the plurality of electrodes based on a command from an external device. For example, the method may comprise receiving, from the external device, a command indicating that initial independent currents should be delivered to the plurality of electrodes. Based on the command, independent currents may be delivered to one or more electrodes of the plurality of electrodes of the stimulation device. The command may be encoded in ultrasonic waves or radio waves emitted by the external device.

[0081] At step 504, the method 500 may comprise generating, by the plurality of electrodes, an initial electric field to stimulate the muscle or the organ comprising a muscle. The initial electric field may be a 2D or 3D current field. The initial electric field generated by the plurality of electrodes may be based on the independent currents delivered by the current sources. The initial electric field may be generated by the plurality of electrodes using initial energy delivered to the stimulation device by the external device. In some embodiments, the method may comprise receiving, from the external device, a command indicating that the initial independent current delivered to one or more electrodes of the plurality of electrodes should be updated. As mentioned above, the command may be encoded in ultrasonic or radio waves emitted by the external device.

[0082] At step 506, the method 500 may comprise delivering an updated independent current to one or more electrodes of the plurality of electrodes. In some embodiments, delivering the updated independent current may comprise updating one or more operating parameters of the one or more current sources electrically coupled to the one or more electrodes to cause the one or more current sources to deliver the updated independent current. Additionally or alternatively, delivering the updated current may comprise updating the current waveform delivered by the control circuit to the one or more current sources. In some embodiments, the updated independent current delivered to a given electrode of the one or more electrodes may be less than the initial independent current delivered to the given electrode of the one or more electrodes. In some embodiments, the updated independent current delivered to the given electrode of the one or more electrodes may be greater than the initial current delivered to the given electrode of the one or more electrodes. In some embodiments, delivering the updated independent current to the given electrode of the one or more electrodes may comprise delivering no current to given electrode of the one or more electrodes (i.e., stopping delivering current to the given electrode).

[0083] At step 508, the method 500 may comprise generating, by the plurality of electrodes, a focused electric field to directly stimulate the muscle or the organ comprising a muscle. The focused electric field may be a 2D or 3D current field.Methods for Stimulating a Muscle or Organ Comprising a Muscle

[0084] In some embodiments, a method for stimulating a muscle or an organ comprising a muscle using the targeted electrical stimulation devices described herein may be provided. For example, the methods provided herein may be used to stimulate a bladder, or a muscle of the bladder wall (e.g., sphincter muscles). The method may comprise delivering energy to the stimulation device. For example, energy may be delivered to the stimulation device via an external device. In some embodiments, the external device may be used to charge the stimulation device prior to stimulation. The stimulation device may comprise a transducer configured to receive the energy from the external device and convert the energy into electric current. The transducer may be electrically coupled to an energy storage that can receive and store the electric current. Each of the current sources of the stimulation device may be electrically coupled to the energy storage to receive the stored electric current. As described herein, each electrode of a plurality of electrodes configured for stimulation may be independently coupled to one or more current sources. Thus, by providing energy to thestimulation device, electric current can be delivered to each of the electrodes in a desired amount for stimulation.

[0085] The method can comprise stimulating the muscle or the organ comprising a muscle using a focused electric field generated by the plurality of electrodes using the energy delivered to the stimulation device. Generating a focused electric field can comprise any one or more steps described herein with respect to method 500 illustrated in FIG. 5. For example, the method may comprise generating an initial electric field using initial currents delivered by the independent current sources, updating one or more of the currents delivered by the independent current sources, and generating an updated, focused electric field using the updated (and, as applicable) initial currents delivered by each of the independent current sources to a given electrode of the plurality of electrodes. As described herein, the initial electric field may be a 2D or 3D current field.Methods for Treatment

[0086] In some embodiments, a method of treatment that includes use of the targeted electrical stimulation device (e.g., device 100, 200, or 300) described herein may be provided. For example, the targeted electrical stimulation device may be used to treat (e.g., alleviate) incontinence or overactive bladder. Electrical stimulation can be used to control a patient’s urge (or lack thereof) to urinate.

[0087] In some embodiments, the method may optionally include implanting the stimulation device (e.g., stimulation device 100, 200, or 300) on a wall of the bladder. For example, at least the portion of the device comprising the electrodes may be implanted on a muscle (e.g., sphincter muscle) of the bladder wall. In some embodiments, as described with respect to the stimulation device 300 illustrated with respect to FIG. 3, one or more paddles comprising electrodes (and current sources / sinks) may be implanted on the bladder wall, and a control unit of the device may be at least partially implanted in the patient of the body, proximate to or a distance away from the one or more paddles.

[0088] In some embodiments, the method of treatment may comprise providing power to the stimulation device to turn on and / or charge the device, for example, by an external device (e.g., an interrogator). Once powered on and charged, the method may comprise initiating a treatment cycle for stimulating the bladder wall. The treatment cycle may comprise delivering an initial current to one or more electrodes, each electrode electrically coupled to an independent current source. Parameters related to the initial current (e.g., intensity, pulse width, pulse duration, etc.) may be provided, for example, automatically by an externaldevice or manually by a user of the external device to the stimulation device. For example, the external device may have stored operating parameters that can be transmitted to the stimulation device, or a user may program operating parameters via the external device. In some embodiments, the stimulation device itself may have stored (e.g., initial) operating parameters, and the external device may transmit a command to initiate delivery of stimulation using the stored operating parameters.

[0089] The independent currents provided to each of the electrodes may in combination generate an initial electric field for stimulation. Data related to the initial electric field, the resulting stimulation therefrom, tissue resistance, etc. (collectively referred to hereinafter as stimulation data) may be measured and recorded. For example, stimulation data may be stored, at least temporarily, in a memory of the stimulation device and / or may be transmitted to an external device for recording and analysis. Based on the stimulation data, the system or a user of the system may determine whether the field for stimulation needs to be adjusted. For example, one or more currents provided to the electrodes may be adjusted to focus the electric field and generate an updated electric field. In some embodiments, one or more currents provided to the electrodes may be automatically adjusted over the course of the treatment cycle in accordance with pre-programmed stimulation parameters. Alternatively, adjusting the electric field may be performed in a similar manner as described herein with respect to method 500 and FIG. 5.

[0090] As described herein, the operating parameters of the current sources may in some embodiments be stored (e.g., in a memory of the stimulation device and / or the external device). For example, the initial current and any updated currents delivered to the electrodes during a given treatment cycle may be stored. In this instance, in later occurrences of the treatment regimen, it may be optional to generate an updated electric field, at least because the initial electric field may be based on stored parameters from past treatment cycles.

[0091] Example parameters - pulse width, duration, current intensity, etc.Definitions

[0092] As used herein, the singular forms “a”, “an”, and “the” include the plural reference unless the context clearly dictates otherwise.

[0093] Reference to “about” a value or parameter herein includes (and describes) variations that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X”.

[0094] It is understood that aspects and variations of the invention described herein include “consisting” and / or “consisting essentially of’ aspects and variations.

[0095] When a range of values or values is provided, it is to be understood that each intervening value between the upper and lower limit of that range, and any other stated or intervening value in that stated range, is encompassed within the scope of the present disclosure. Where the stated range includes upper or lower limits, ranges excluding either of those included limits are also included in the present disclosure.

[0096] The section headings used herein are for organization purposes only and are not to be construed as limiting the subject matter described. The description is presented to enable one of ordinary skill in the art to make and use the invention and is provided in the context of a patent application and its requirements. Various modifications to the described embodiments will be readily apparent to those persons skilled in the art and the generic principles herein may be applied to other embodiments. Thus, the present invention is not intended to be limited to the embodiment shown but is to be accorded the widest scope consistent with the principles and features described herein.

[0097] The figures illustrate processes according to various embodiments. In the exemplary processes, some blocks are, optionally, combined, the order of some blocks is, optionally, changed, and some blocks are, optionally, omitted. In some examples, additional steps may be performed in combination with the exemplary processes. Accordingly, the operations as illustrated (and described in greater detail below) are exemplary by nature and, as such, should not be viewed as limiting.

[0098] Finally, it is to be understood that features and preferences described in relation to “embodiments” are distinct preferences and are not limited only to that particular embodiment; they may be freely combined with features from other embodiments, where technically feasible, and may form preferred combinations of features. The description is presented to enable one of ordinary skill in the art to make and use the invention and is provided in the context of a patent application and its requirements. Various modifications to the described embodiments will be readily apparent to those persons skilled in the art and the generic principles herein may be applied to other embodiments. Thus, the present invention is not intended to be limited to the embodiment shown but is to be accorded the widest scope consistent with the principles and features described herein. Further, sectional headings are provided for organizational purposes and are not to be considered limiting.

[0099] The entire disclosure of the patents and publications referred in this application are hereby incorporated herein by reference for all purposes. To the extent that any referenceincorporated by reference conflicts with the instant disclosure, the instant disclosure shall control.EMBODIMENTS

[0100] The following embodiments are exemplary and are not intended to limit the scope of any invention described herein.

[0101] Embodiment 1. A stimulation device, comprising: a plurality of current sources; and a plurality of electrodes electrically coupled to the plurality of current sources, the plurality of electrodes configured to directly stimulate a muscle or an organ comprising a muscle, wherein each electrode of the plurality of electrodes is configured to be operated using an independent current source of the plurality of current sources.

[0102] Embodiment 2. The stimulation device of embodiment 1, wherein each current source of the plurality of current sources is electrically coupled in series through the muscle or the organ comprising the muscle to at least one other current source of the plurality of current sources.

[0103] Embodiment 3. The stimulation device of embodiment 1 or 2, wherein the independent current source of the plurality of current sources is configured to supply or absorb a current that is independent of currents supplied or absorbed by other current sources of the plurality of current sources.

[0104] Embodiment 4. The stimulation device of any one of embodiments 1-3, wherein currents supplied by the plurality of current sources are adjustable by a control circuit electrically coupled to each current source of the plurality of current sources.

[0105] Embodiment 5. The stimulation device of any one of embodiments 1-4, wherein at least one current source of the plurality of current sources is adjustable between supplying current or absorbing current by a control circuit electrically coupled to the at least one current source.

[0106] Embodiment 6. The stimulation device of any one of embodiments 1-5, comprising a switch electrically coupled to the independent current source to control whether the independent current source supplies current to or absorbs current from the electrode.

[0107] Embodiment 7. The stimulation device of any one of embodiments 1-6, wherein the plurality of electrodes are configured to generate, based on independent currents from the plurality of current sources, a focusable electrical stimulation field for targeted stimulation of the muscle or the organ comprising a muscle.

[0108] Embodiment 8. The stimulation device of embodiment 7, wherein the electrical stimulation field is a two-dimensional current field or a three-dimensional current field.

[0109] Embodiment 9. The stimulation device of any one of embodiments 1-8, comprising a control circuit electrically coupled to each current source of the plurality of current sources and configured to generate a current waveform to be delivered to the plurality of current sources.

[0110] Embodiment 10. The stimulation device of embodiment 9, wherein the control circuit is configured to receive a command from an external device, the command configured to cause the control circuit to deliver the current waveform to one or more current sources of the plurality of current sources.[oni] Embodiment 11. The stimulation device of embodiment 9, wherein the stimulation device comprises one or more ultrasonic transducers, and the control circuit receives the command from ultrasonic waves emitted by the external device.

[0112] Embodiment 12. The stimulation device of embodiment 10 or 11, wherein the control circuit is configured to communicate with the external device using ultrasonic backscatter.

[0113] Embodiment 13. The stimulation device of embodiment 10, wherein the stimulation device comprises a radio frequency (RF) antenna, and the control circuit receives the command from radio waves emitted by the external device.

[0114] Embodiment 14. The stimulation device of embodiment 10 or 13, wherein the control circuit is configured to communicate with the external device using radio wave backscatter.

[0115] Embodiment 15. The stimulation device of any one of embodiments 1-10 or 13- 14, wherein the stimulation device comprises a radiofrequency (RF) antenna, and the plurality of current sources are configured to receive energy from RF waves emitted by an external device.

[0116] Embodiment 16. The stimulation device of any one of embodiments 1-12, wherein the stimulation device comprises one or more ultrasonic transducers, and the plurality of current sources are configured to receive energy from ultrasonic waves emitted by the external device.

[0117] Embodiment 17. The stimulation device of any one of embodiments 1-16, wherein a first portion of the plurality of electrodes are disposed on a first paddle configured to be implanted at a first location in the muscle or the organ comprising a muscle and a secondportion of the plurality of electrodes are disposed on a second paddle configured to be implanted at a second location in the muscle or the organ comprising a muscle.

[0118] Embodiment 18. The stimulation device of embodiment 17, wherein the first paddle and / or the second paddle comprise a conductive shell that is configured as an electrode.

[0119] Embodiment 19. The stimulation device of any one of embodiments 1-18, comprising one or more stimulation leads that electrically couple each of the plurality of electrodes to an independent current source of the plurality of current sources.

[0120] Embodiment 20. The stimulation device of any one of embodiments 1-19, comprising an energy storage electrically coupled to the plurality of current sources.

[0121] Embodiment 21. The stimulation device of any one of embodiments 1-20, wherein the plurality of electrodes comprises at least one anode and at least one cathode that together are configured to deliver bipolar stimulation to the muscle or the organ comprising a muscle.

[0122] Embodiment 22. The stimulation device of any one of embodiments 1-21, wherein at least a portion of the plurality of current sources are configured to act as current sinks that absorb current.

[0123] Embodiment 23. The stimulation device of any one of embodiments 1-22, wherein the plurality of current sources comprises one or more transistors.

[0124] Embodiment 24. The stimulation device of any one of embodiments 1-23, wherein the plurality of electrodes are configured to directly stimulate a bladder wall to trigger bladder voiding.

[0125] Embodiment 25. A stimulation system, comprising: the stimulation device of any one of embodiments 1-24; and an external device configured to communicate with the stimulation device.

[0126] Embodiment 26. The stimulation system of embodiment 25, comprising a magnet configured to power the stimulation device on and / or off.

[0127] Embodiment 27. A method for stimulating a muscle or an organ comprising a muscle, comprising: delivering energy to the stimulation device of any one of embodiments 1-26; and stimulating the muscle or the organ comprising a muscle using a focused electric field generated by the plurality of electrodes using the energy delivered to the stimulation device.

[0128] Embodiment 28. The method of embodiment 27, comprising: delivering an initial energy to the stimulation device; and stimulating the muscle or the organ comprising amuscle using an initial electric field generated by the plurality of electrodes using the initial energy delivered to the stimulation device.

[0129] Embodiment 29. The method of embodiment 27 or 28, wherein the energy is delivered using an external device.

[0130] Embodiment 30. The method of embodiment 29, wherein the energy is delivered using ultrasonic waves emitted by the external device.

[0131] Embodiment 31. The method of embodiment 29, wherein the energy is delivered using radio waves emitted by the external device.

[0132] Embodiment 32. The method of any one of embodiments 27-31, comprising transmitting one or more commands to the stimulation device indicating operating parameters of the stimulation device.

[0133] Embodiment 33. The method of embodiment 32, wherein the command is encoded in ultrasonic waves emitted by the external device.

[0134] Embodiment 34. The method of embodiment 32, wherein the command is encoded in radio waves emitted by the external device.

[0135] Embodiment 35. A method for treating a bladder incontinence in a subject in need of treatment for the bladder incontinence, comprising administering electrical stimulation using the stimulation device of any one of embodiments 1-26.

[0136] Embodiment 36. A method for generating a focused electric field to stimulate a muscle or an organ comprising a muscle, comprising: delivering initial independent currents to a plurality of electrodes implanted on the muscle or the organ comprising a muscle; generating, by the plurality of electrodes, an initial electric field to stimulate the muscle or the organ comprising a muscle; delivering an updated independent current to one or more electrodes of the plurality of electrodes; and generating, by the plurality of electrodes, a focused electric field to directly stimulate the muscle or the organ comprising a muscle.

[0137] Embodiment 37. The method of embodiment 36, wherein the initial independent currents delivered to the plurality of electrodes are supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes.

[0138] Embodiment 38. The method of embodiment 37, wherein each electrode of the plurality of electrodes is operated using an independent current source of the plurality of current sources and each of the plurality of current sources are configured to absorb or supply a current that is independent of currents supplied or absorbed by other current sources of the plurality of current sources.

[0139] Embodiment 39. The method of embodiment 37 or 38, wherein currents supplied by the plurality of current sources are adjustable by a control circuit electrically coupled to each current source of the plurality of current sources.

[0140] Embodiment 40. The method of any one of embodiments 37-39, wherein at least one current source of the plurality of current sources is adjustable between supplying current or absorbing current by a control circuit electrically coupled to the at least one current source.

[0141] Embodiment 41. The method of any one of embodiments 38-40, wherein a switch electrically coupled to the independent current source of the plurality of current sources is configured to control whether the independent current source supplies current to or absorbs current from the electrode.

[0142] Embodiment 42. The method of any one of embodiments 37-41, wherein delivering an updated independent current to one or more electrodes of the plurality of electrodes comprises updating one or more operating parameters of one or more current sources of the plurality of electrodes electrically coupled to the one or more electrodes to cause the one or more current sources to deliver the updated independent current.

[0143] Embodiment 43. The method of any one of embodiments 37-42, wherein delivering an updated independent current to one or more electrodes of the plurality of electrodes comprises updating a current waveform delivered to the one or more current sources.

[0144] Embodiment 44. The method of any one of embodiments 36-43, wherein the updated independent current delivered to a given electrode of the one or more electrodes is less than the initial independent current delivered to the given electrode of the one or more electrodes.

[0145] Embodiment 45. The method of any one of embodiments 36-43, wherein the updated independent current delivered to a given electrode of the one or more electrodes is greater than the initial independent current delivered to the given electrode of the one or more electrodes.

[0146] Embodiment 46. The method of any one of embodiments 36-45, wherein delivering an updated independent current to a given electrode of the one or more electrodes comprises delivering no current to the given electrode of the one or more electrodes.

[0147] Embodiment 47. The method of any one of embodiments 36-46, wherein the plurality of electrodes comprises at least one anode and at least one cathode that together deliver bipolar stimulation to the muscle or the organ comprising a muscle when the initial electric field and / or the focused electric field are generated.

[0148] Embodiment 48. The method of any one of embodiments 36-47, comprising receiving energy from an external device.

[0149] Embodiment 49. The method of embodiment 48, wherein the energy is received from ultrasonic waves emitted by the external device.

[0150] Embodiment 50. The method of embodiment 48, wherein the energy is received from radio waves emitted by the external device.

[0151] Embodiment 51. The method of any one of embodiments 36-50, comprising: receiving, from an external device, a command indicating that the initial independent currents should be delivered to the plurality of electrodes; and delivering the initial independent currents to the one or more electrodes of the plurality of electrodes.

[0152] Embodiment 52. The method of embodiment 51, wherein the command is encoded in ultrasonic waves emitted by the external device.

[0153] Embodiment 53. The method of embodiment 51, wherein the command is encoded in radio waves emitted by the external device.

[0154] Embodiment 54. The method of any one of embodiments 36-53, comprising: receiving, from an external device, a command indicating that the initial independent current delivered to one or more electrodes of the plurality of electrodes should be updated; and delivering the updated independent current to the one or more electrodes of the plurality of electrodes.

[0155] Embodiment 55. The method of embodiment 54, wherein the command is encoded in ultrasonic waves emitted by the external device.

[0156] Embodiment 56. The method of embodiment 55, wherein the command is encoded in radio waves emitted by the external device.

[0157] Embodiment 57. The method of any one of embodiments 36-56, comprising communicating with an external device using ultrasonic backscatter.

[0158] Embodiment 58. The method of any one of embodiments 36-56, comprising communicating with an external device using radio wave backscatter.

[0159] Embodiment 59. The method of any one of embodiments 36-58, wherein each of the initial electric field and the focused electric field are a two-dimensional current field or a three-dimensional current field.

[0160] Embodiment 60. A method for treating a bladder incontinence in a subject in need of treatment for the bladder incontinence, comprising administering electrical stimulation in accordance with the method of any one of embodiments 36-59.

[0161] Embodiment 61. The stimulation device of embodiment 10 or 11, wherein the control circuit is configured to communicate with the external device using active ultrasonic wave transmission.

[0162] Embodiment 62. The stimulation device of embodiment 10 or 13, wherein the control circuit is configured to communicate with the external device using active radio wave transmission.

[0163] Embodiment 63. The method of any one of embodiments 36-56, comprising communicating with an external device using active ultrasonic wave transmission.

[0164] Embodiment 64. The method of any one of embodiments 36-56, comprising communicating with an external device using active radio wave transmission.Conclusion

[0165] The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated.

[0166] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims.

Claims

CLAIMSWhat is claimed is:

1. A stimulation device, comprising: a plurality of current sources; and a plurality of electrodes electrically coupled to the plurality of current sources, the plurality of electrodes configured to directly stimulate a muscle or an organ comprising a muscle, wherein each electrode of the plurality of electrodes is configured to be operated using an independent current source of the plurality of current sources.

2. The stimulation device of claim 1, wherein each current source of the plurality of current sources is electrically coupled in series through the muscle or the organ comprising the muscle to at least one other current source of the plurality of current sources.

3. The stimulation device of claim 1 or 2, wherein the independent current source of the plurality of current sources is configured to supply or absorb a current that is independent of currents supplied or absorbed by other current sources of the plurality of current sources.

4. The stimulation device of any one of claims 1-3, wherein currents supplied by the plurality of current sources are adjustable by a control circuit electrically coupled to each current source of the plurality of current sources.

5. The stimulation device of any one of claims 1-4, wherein at least one current source of the plurality of current sources is adjustable between supplying current or absorbing current by a control circuit electrically coupled to the at least one current source.

6. The stimulation device of any one of claims 1-5, comprising a switch electrically coupled to the independent current source to control whether the independent current source supplies current to or absorbs current from the electrode.

7. The stimulation device of any one of claims 1-6, wherein the plurality of electrodes are configured to generate, based on independent currents from the plurality of current sources, a focusable electrical stimulation field for targeted stimulation of the muscle or the organ comprising a muscle.

8. The stimulation device of claim 7, wherein the electrical stimulation field is a two- dimensional current field or a three-dimensional current field.

9. The stimulation device of any one of claims 1-8, comprising a control circuit electrically coupled to each current source of the plurality of current sources and configured to generate a current waveform to be delivered to the plurality of current sources.

10. The stimulation device of claim 9, wherein the control circuit is configured to receive a command from an external device, the command configured to cause the control circuit to deliver the current waveform to one or more current sources of the plurality of current sources.

11. The stimulation device of claim 9, wherein the stimulation device comprises one or more ultrasonic transducers, and the control circuit receives the command from ultrasonic waves emitted by the external device.

12. The stimulation device of claim 10 or 11, wherein the control circuit is configured to communicate with the external device using ultrasonic backscatter.

13. The stimulation device of claim 10, wherein the stimulation device comprises a radio frequency (RF) antenna, and the control circuit receives the command from radio waves emitted by the external device.

14. The stimulation device of claim 10 or 13, wherein the control circuit is configured to communicate with the external device using radio wave backscatter.

15. The stimulation device of any one of claims 1-10 or 13-14, wherein the stimulation device comprises a radiofrequency (RF) antenna, and the plurality of current sources are configured to receive energy from RF waves emitted by an external device.

16. The stimulation device of any one of claims 1-12, wherein the stimulation device comprises one or more ultrasonic transducers, and the plurality of current sources are configured to receive energy from ultrasonic waves emitted by the external device.

17. The stimulation device of any one of claims 1-16, wherein a first portion of the plurality of electrodes are disposed on a first paddle configured to be implanted at a first location in the muscle or the organ comprising a muscle and a second portion of the plurality of electrodes are disposed on a second paddle configured to be implanted at a second location in the muscle or the organ comprising a muscle.

18. The stimulation device of claim 17, wherein the first paddle and / or the second paddle comprise a conductive shell that is configured as an electrode.

19. The stimulation device of any one of claims 1-18, comprising one or more stimulation leads that electrically couple each of the plurality of electrodes to an independent current source of the plurality of current sources.

20. The stimulation device of any one of claims 1-19, comprising an energy storage electrically coupled to the plurality of current sources.

21. The stimulation device of any one of claims 1-20, wherein the plurality of electrodes comprises at least one anode and at least one cathode that together are configured to deliver bipolar stimulation to the muscle or the organ comprising a muscle.

22. The stimulation device of any one of claims 1-21, wherein at least a portion of the plurality of current sources are configured to act as current sinks that absorb current.

23. The stimulation device of any one of claims 1-22, wherein the plurality of current sources comprises one or more transistors.

24. The stimulation device of any one of claims 1-23, wherein the plurality of electrodes are configured to directly stimulate a bladder wall to trigger bladder voiding.

25. A stimulation system, comprising: the stimulation device of any one of claims 1-24; and an external device configured to communicate with the stimulation device.

26. The stimulation system of claim 25, comprising a magnet configured to power the stimulation device on and / or off.

27. A method for stimulating a muscle or an organ comprising a muscle, comprising: delivering energy to the stimulation device of any one of claims 1-26; and stimulating the muscle or the organ comprising a muscle using a focused electric field generated by the plurality of electrodes using the energy delivered to the stimulation device.

28. The method of claim 27, comprising: delivering an initial energy to the stimulation device; and stimulating the muscle or the organ comprising a muscle using an initial electric field generated by the plurality of electrodes using the initial energy delivered to the stimulation device.

29. The method of claim 27 or 28, wherein the energy is delivered using an external device.

30. The method of claim 29, wherein the energy is delivered using ultrasonic waves emitted by the external device.

31. The method of claim 29, wherein the energy is delivered using radio waves emitted by the external device.

32. The method of any one of claims 27-31, comprising transmitting one or more commands to the stimulation device indicating operating parameters of the stimulation device.

33. The method of claim 32, wherein the command is encoded in ultrasonic waves emitted by the external device.

34. The method of claim 32, wherein the command is encoded in radio waves emitted by the external device.

35. A method for treating a bladder incontinence in a subject in need of treatment for the bladder incontinence, comprising administering electrical stimulation using the stimulation device of any one of claims 1-26.

36. A method for generating a focused electric field to stimulate a muscle or an organ comprising a muscle, comprising: delivering initial independent currents to a plurality of electrodes implanted on the muscle or the organ comprising a muscle; generating, by the plurality of electrodes, an initial electric field to stimulate the muscle or the organ comprising a muscle; delivering an updated independent current to one or more electrodes of the plurality of electrodes; and generating, by the plurality of electrodes, a focused electric field to directly stimulate the muscle or the organ comprising a muscle.

37. The method of claim 36, wherein the initial independent currents delivered to the plurality of electrodes are supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes.

38. The method of claim 37, wherein each electrode of the plurality of electrodes is operated using an independent current source of the plurality of current sources and each of the plurality of current sources are configured to absorb or supply a current that is independent of currents supplied or absorbed by other current sources of the plurality of current sources.

39. The method of claim 37 or 38, wherein currents supplied by the plurality of current sources are adjustable by a control circuit electrically coupled to each current source of the plurality of current sources.

40. The method of any one of claims 37-39, wherein at least one current source of the plurality of current sources is adjustable between supplying current or absorbing current by a control circuit electrically coupled to the at least one current source.

41. The method of any one of claims 38-40, wherein a switch electrically coupled to the independent current source of the plurality of current sources is configured to control whether the independent current source supplies current to or absorbs current from the electrode.

42. The method of any one of claims 37-41, wherein delivering an updated independent current to one or more electrodes of the plurality of electrodes comprises updating one or more operating parameters of one or more current sources of the plurality of electrodes electrically coupled to the one or more electrodes to cause the one or more current sources to deliver the updated independent current.

43. The method of any one of claims 37-42, wherein delivering an updated independent current to one or more electrodes of the plurality of electrodes comprises updating a current waveform delivered to the one or more current sources.

44. The method of any one of claims 36-43, wherein the updated independent current delivered to a given electrode of the one or more electrodes is less than the initial independent current delivered to the given electrode of the one or more electrodes.

45. The method of any one of claims 36-43, wherein the updated independent current delivered to a given electrode of the one or more electrodes is greater than the initial independent current delivered to the given electrode of the one or more electrodes.

46. The method of any one of claims 36-45, wherein delivering an updated independent current to a given electrode of the one or more electrodes comprises delivering no current to the given electrode of the one or more electrodes.

47. The method of any one of claims 36-46, wherein the plurality of electrodes comprises at least one anode and at least one cathode that together deliver bipolar stimulation to the muscle or the organ comprising a muscle when the initial electric field and / or the focused electric field are generated.

48. The method of any one of claims 36-47, comprising receiving energy from an external device.

49. The method of claim 48, wherein the energy is received from ultrasonic waves emitted by the external device.

50. The method of claim 48, wherein the energy is received from radio waves emitted by the external device.

51. The method of any one of claims 36-50, comprising: receiving, from an external device, a command indicating that the initial independent currents should be delivered to the plurality of electrodes; and delivering the initial independent currents to the one or more electrodes of the plurality of electrodes.

52. The method of claim 51, wherein the command is encoded in ultrasonic waves emitted by the external device.

53. The method of claim 51, wherein the command is encoded in radio waves emitted by the external device.

54. The method of any one of claims 36-53, comprising: receiving, from an external device, a command indicating that the initial independent current delivered to one or more electrodes of the plurality of electrodes should be updated; and delivering the updated independent current to the one or more electrodes of the plurality of electrodes.

55. The method of claim 54, wherein the command is encoded in ultrasonic waves emitted by the external device.

56. The method of claim 55, wherein the command is encoded in radio waves emitted by the external device.

57. The method of any one of claims 36-56, comprising communicating with an external device using ultrasonic backscatter.

58. The method of any one of claims 36-56, comprising communicating with an external device using radio wave backscatter.

59. The method of any one of claims 36-58, wherein each of the initial electric field and the focused electric field are a two-dimensional current field or a three-dimensional current field.

60. A method for treating a bladder incontinence in a subject in need of treatment for the bladder incontinence, comprising administering electrical stimulation in accordance with the method of any one of claims 36-59.

61. The stimulation device of claim 10 or 11, wherein the control circuit is configured to communicate with the external device using active ultrasonic wave transmission.

62. The stimulation device of claim 10 or 13, wherein the control circuit is configured to communicate with the external device using active radio wave transmission.

63. The method of any one of claims 36-56, comprising communicating with an external device using active ultrasonic wave transmission.

64. The method of any one of claims 36-56, comprising communicating with an external device using active radio wave transmission.

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